Dimensional Brain Behavior Predictors of CBT Outcomes in Pediatric Anxiety (NCT02810171) | Clinical Trial Compass
CompletedNot Applicable
Dimensional Brain Behavior Predictors of CBT Outcomes in Pediatric Anxiety
United States207 participantsStarted 2016-12
Plain-language summary
Anxiety is among the most prevalent, costly and disabling illnesses and tends emerge early in childhood. Cognitive behavioral therapy (CBT) is the first-line treatment for early life anxiety, but as many as 40% of young patients who receive CBT fail to get better. The proposed study will examine brain changes marking positive response to CBT for anxiety and how these changes may differ in children compared adolescents. By helping us to understand how CBT works, this study will pave the way for new treatments to stop anxiety early.
Who can participate
Age range
7 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for all participants (Clinically Anxious and Healthy):
* Age 7.0 - 17.99 years
* Parent or guardian able and willing to give informed consent
* Ability to tolerate small, enclosed spaces
Exclusion criteria for all participants (Clinically Anxious and Healthy)
* No metals, implants or metallic substances within or on the body (e.g., orthodontic braces)
* Vision equal to or better than 20/30 on a Snelling chart, with correction if necessary
* Not currently taking any psychotropic medication or receiving any psychotherapy (stable doses of stimulants allowable for anxiety subjects with comorbid attention deficit hyperactivity disorder) or receiving hormone therapy other than birth control
* No lifetime diagnoses of psychotic disorder, mental retardation or autism
* No history of current substance/alcohol abuse/dependence
* No evidence of suicidal intentions or behaviors in the past 6 months
* No history of serious medical or neurological illness
* If post-pubertal female, not pregnant
Additional Inclusion Criteria for Clinically Anxious Participants:
* Clinically significant anxiety as determined by structured clinical interview
* Past history of major depressive episodes are allowable
* Past history substance/alcohol abuse allowable if in remission for at least 1 year
* Obsessive-compulsive disorder symptoms are acceptable if not the primary source of interference or distress
* Anxiety must be primary concern, still bothersome, and CBT for anxiety determi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Brain function/structure as assessed by Magnetic Resonance Imaging scans